NCT00661947

Brief Summary

The purpose of this study is to determine whether sucrose vs high fructose corn syrup from a soft drink results in differences in various metabolic byproducts such as fructose, glucose, serum uric acid, triglyceride and lactate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

February 16, 2012

Status Verified

October 1, 2011

Enrollment Period

2.4 years

First QC Date

April 16, 2008

Last Update Submit

February 14, 2012

Conditions

Healthy

Keywords

fructosesucrosehigh fructose corn syrupserum uric acidlactateglucosetriglyceridesBioavailability of fructose from two formulations

Outcome Measures

Primary Outcomes (1)

  • Fructose

    baseline, 15min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr

Secondary Outcomes (4)

  • serum uric acid

    baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr

  • glucose

    baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr

  • lactate

    baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr

  • triglycerides

    baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr

Study Arms (1)

Public

General public. Those who are not currently taking any medication besides birth control pills.

Other: Dr Pepper sweetened with sucrose or high fructose corn syrup

Interventions

Dr Pepper sweetened with sucrose or high fructose corn syrupOTHER

Comparison of different formulations of fructose.

Public

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General population from Gainesville, FL area.

You may qualify if:

  • adult subjects aged 18 years or older
  • either gender
  • any ethnicity
  • willing to abstain from drinking any alcohol 3 days prior to a study visit

You may not qualify if:

  • history of liver or kidney disease
  • history of diabetes mellitus or fasting blood glucose ≥ 126 mg/dl or random blood glucose ≥ 200 mg/dl
  • currently taking any medication (except oral contraceptives)
  • consume more than 1 alcoholic drink per day
  • pregnant or breast-feeding
  • blood donor in the previous 8 weeks
  • history of gout

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida, Department of Pharmacy Practice, Center for Pharmacogenomics

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

  • Le MT, Frye RF, Rivard CJ, Cheng J, McFann KK, Segal MS, Johnson RJ, Johnson JA. Effects of high-fructose corn syrup and sucrose on the pharmacokinetics of fructose and acute metabolic and hemodynamic responses in healthy subjects. Metabolism. 2012 May;61(5):641-51. doi: 10.1016/j.metabol.2011.09.013. Epub 2011 Dec 5.

    PMID: 22152650RESULT

Biospecimen

Retention: SAMPLES WITH DNA

DNA, whole blood, serum, plasma, and urine

MeSH Terms

Interventions

SucroseHigh Fructose Corn Syrup

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsDietary SugarsDietary CarbohydratesNutritive SweetenersSweetening AgentsFlavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Julie A Johnson, Pharm.D.

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2008

First Posted

April 21, 2008

Study Start

March 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

February 16, 2012

Record last verified: 2011-10

Locations

US(1)